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- Alberto Garcia-Rodriguez, Luis, et al.
(författare)
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Rationale and design of a European epidemiological post-authorization safety study (PASS) program : rivaroxaban use in routine clinical practice
- 2020
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Ingår i: Expert Opinion on Drug Safety. - : TAYLOR & FRANCIS LTD. - 1474-0338 .- 1744-764X. ; 19:11, s. 1513-1520
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Tidskriftsartikel (refereegranskat)abstract
- Background Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. Study design and methods The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from health-care databases in the UK, the Netherlands, Germany, and Sweden. These database studies describe patterns of rivaroxaban use and patient characteristics over time, and investigate safety and effectiveness outcomes in new users of rivaroxaban using a cohort analysis and nested case-control analysis. To put these results in context, safety outcomes are also analyzed in new users of standard of care. In addition, a modified prescription event monitoring study conducted in the early post-launch phase in primary care, and two specialist cohort event monitoring studies that investigated rivaroxaban use in the secondary care hospital setting, systematically collected drug utilization and safety data via questionnaires completed by health-care professionals in the UK. Discussion The European rivaroxaban epidemiological PASS is a comprehensive program of complementary studies generating evidence from patients treated in routine clinical practice that will expand our understanding of the risk-benefit profile of rivaroxaban.
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| 4. |
- Bardel, Annika, 1952-, et al.
(författare)
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Age and sex related self-reported symptoms in a general population across 30 years: Patterns of reporting and secular trend
- 2019
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Ingår i: Plos One. - : Public Library of Science (PLoS). - 1932-6203. ; 14:2
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Tidskriftsartikel (refereegranskat)abstract
- Objective :To study age and sex specific prevalence of 30 symptoms in random samples from the general population and to analyze possible secular trends across time. Study population: The study was based on data from eight on-going Swedish cohort studies, with baseline investigations performed between 1973 and 2003. Samples were drawn from the general population of the cities of Gothenburg and Eskilstuna, and of Uppsala County. Overall, 20,160 subjects were sampled, 14,470 (71.8%) responded, of whom 12.000 were unique subjects, and 2548 were part of more than one sample. Methods: The Complaint score sub-scale of the Gothenburg Quality of Life instrument, listing 30 general symptoms was used. Responders were asked to indicate which symptoms they had experienced during the last three months. Results: Women reported on average 7.8 symptoms, and men 5.3 (p<0.0001). Women reported higher prevalence than men for 24 of the 30 symptoms. In multivariate analyses four patterns of prevalence across age were identified in both men and women; increasing prevalence, decreasing, stable and biphasic prevalence. The symptoms in the various pattern groups differed somewhat between men and women. However, symptoms related to strain were prominent among symptoms decreasing with age. Moreover, there were secular trends. Across all symptoms reporting prevalence increased over time in men (p<0.001) as well as in women (p<0.0001). Conclusions: Women reported higher total symptom prevalence than men. Symptoms related to health generally increased with age, while symptoms related to stress decreased markedly. Significant secular trends across time regarding symptom prevalence were found. © 2019 Bardel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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| 5. |
- Bardel, Annika, et al.
(författare)
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Age-specific symptom prevalence in women 35-64 years old : A population-based study
- 2009
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Ingår i: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 9, s. 37-
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Symptom prevalence is generally believed to increase with age. The aim of this study was to evaluate the age specific prevalence of 30 general symptoms among Swedish middle-aged women. METHODS: A cross-sectional postal questionnaire study in seven Swedish counties in a random sample of 4,200 women 35-64 years old, with 2,991 responders. Thirty general symptoms included in the Complaint Score subscale of the Gothenburg Quality of Life Instrument were used. RESULTS: Four groups of age specific prevalence patterns were identified after adjustment for the influence of educational level, perceived health and mood, body mass index, smoking habits, use of hormone replacement therapy, and use of other symptom relieving therapy. Only five symptoms (insomnia, leg pain, joint pain, eye problems and impaired hearing) increased significantly with age. Eleven symptoms (general fatigue, headache, irritability, melancholy, backache, exhaustion, feels cold, cries easily, abdominal pain, dizziness, and nausea) decreased significantly with age. Two symptoms (sweating and impaired concentration) had a biphasic course with a significant increase followed by a significant decrease. The remaining twelve symptoms (difficulty in relaxing, restlessness, overweight, coughing, breathlessness, diarrhoea, chest pain, constipation, nervousness, poor appetite, weight loss, and difficulty in urinating) had stable prevalence with age. CONCLUSION: Symptoms did not necessarily increase with age instead symptoms related to stress-tension-depression decreased.
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| 7. |
- Bardel, Annika, et al.
(författare)
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Factors associated with adherence to drug therapy : a population-based study
- 2007
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Ingår i: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 0031-6970 .- 1432-1041. ; 63:3, s. 307-314
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Tidskriftsartikel (refereegranskat)abstract
- Objective To investigate adherence to prescription in a female population aged 35–65 years. Design Postal questionnaire study of 2991 randomly sampled 35- to 64-year-old women in seven provinces of central Sweden. Methods The study was performed in 1995 as a cross-sectional postal questionnaire study in seven counties in central Sweden. The questionnaire was sent to a random sample of 4200 women between the ages of 35 and 64, of whom 2991 (71.2%) responded. The questionnaire asked about drugs prescribed during the past year and about factors potentially affecting adherence. Results The same women had different degrees of adherence to different medications. A large number of factors were associated with adherence. Multivariate analysis revealed that age, scheduled check-up, perceived importance of medication, concerns about medication safety and taking medication for a respiratory or a cardiovascular disease were significantly related to adherence. Adherence ranged from 15–98% depending on these factors, and was the lowest among young women who regarded their medication as unimportant and who had no scheduled check-up; the highest reported adherence was found among elderly women who regarded their medication as important and who had a scheduled check-up. Conclusion Factors that were associated with the perceived importance of medication had a positive effect on adherence, while concerns about medication safety had a negative effect.
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- Bardel, Annika, 1952-, et al.
(författare)
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Factors associated with adherence to drug therapy
- 2015
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Ingår i: The world book of family medicine. - Ljubljana : Narodna in univerzitetna. - 9789612819835 ; , s. 100-102
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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